Acute Subdural Hematoma

NCT07490197 — Recruiting, 100 participants, Methodist Health System

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Acute Subdural Hematoma Registry

RegistryNCT07490197
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorMethodist Health System (Other)
ConditionsTrauma
InterventionsMedical/Phenotype Data Collection Procedures & Data to be Collected (Other)
Datesstart 2024-01-30, primary completion 2027-02-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-03-24, last updated 2026-08-04
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Trauma All trials of Medical/Phenotype Data Collection Procedures & Data to be Collected

-Summary

This retrospective data repository will serve as a means to aggregate and analyze standard surgical interventions and Middle Meningeal Arteryembolization as suitable treatment options for Acute Subdural Hematoma.

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+Detailed description

The primary objective of this study is to establish a data repository permissive of quality improvement studies/observations specific to patients with Acute Subdural Hematoma and evaluate impact of surgical interventions like burr hole trephination, Craniotomy, Decompressive Craniectomy, and Middle Meningeal Arteryembolization embolization on survival outcomes.

+Arms and interventions

ArmTypeInterventionsDescription
Total Number and Description of Study Sites/Total Number of SubjectsOther: Medical/Phenotype Data Collection Procedures & Data to be CollectedThis study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established.
  • Medical/Phenotype Data Collection Procedures & Data to be Collected (Other): TheMethodist Dallas Medical Center Trauma Registry will be queried for demographic information, diagnosis codes, admission dates, traumatic injury characteristics, surgical procedures, comorbidities, inpatient outcomes, complications, consultations, discharge location, and mortality. Additional laboratory values will be abstracted from Epic through retrospective chart review.

+Outcome measures

Primary outcomes

  • Total Number of Study Sites [5 years]: This study will include all trauma patients who meet registry inclusion and arrive at the Methodist Dallas Medical Center trauma bay with Acute subdural hematoma . Enrollment will terminate once adequate number of interventions have been observed for clinical significance to be established. We anticipate 5 years of data to be captured (January 2018 through December 2023).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* ≥18 years old
* Included in the Methodist Dallas Medical Center Trauma Registry
* Acute subdural hematoma identified on computed tomography scan or magnetic resonance imaging of the brain in the trauma bay within 72 hours of a traumatic event

Exclusion Criteria:

* <18 years old
* Prisoners, pregnant persons, or other protected population

+Locations (1)

FacilityCityCountryStatus
Methodist Dallas Medical Center- Clinical Research InstituteDallas, TexasUnited StatesRecruiting

+Investigators